MAUDE Adverse Event Report: ANALOG DEVICES SENSINEL CARDIOPULMONARY MANAGEMENT SYSTEM

Model Number	ADCP1100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During routine data monitoring on (b)(6) 2025, the team noticed an erratic pattern in some measurement signals.Analog notified the patient and healthcare provider of the identified issue and advised the patient to discontinue using the device.On (b)(6) 2025, a retrospective review of the patient data found inaccurate readings in 5 of 24 diastolic heart sound strength measurements (20.83%).Two abnormal signal patterns were observed: (1) a shift in the acoustic signal away from its expected baseline and (2) abrupt simultaneous jumps/falls in both acoustic and impedance signals.These anomalies did not align with common user errors or poor device contact, suggesting a potential hardware malfunction.On (b)(6) 2025, analog notified the patient and the healthcare provider of the identified issue and advised the patient to discontinue using the device.There were no adverse events or no need for medical intervention related to this malfunction.The device has not yet been returned for evaluation to confirm the suspected hardware malfunction.However, the reported signal characteristics are consistent with a recent pattern of acoustic wire-break issues that analog is addressing through an active capa.
Event or Problem Description
During routine data monitoring on (b)(6) 2025, the team noticed an erratic pattern in some measurement signals.On (b)(6) 2025, a retrospective review of the patient data found inaccurate readings in 5 of 24 diastolic heart sound strength measurements (20.83%).Two abnormal signal patterns were observed: (1) a shift in the acoustic signal away from its expected baseline and (2) abrupt simultaneous jumps/falls in both acoustic and impedance signals.These anomalies did not align with common user errors or poor device contact, suggesting a potential hardware malfunction.

• Brand Name: SENSINEL CARDIOPULMONARY MANAGEMENT SYSTEM
• Common Device Name: CARDIOPULMONARY MANAGEMENT SYSTEM
• Manufacturer (Section D): ANALOG DEVICES; 1 analog way; wilmington MA 01887
• Manufacturer (Section G): NEXT PHASE MEDICAL DEVICES; 110 forbes blvd; mansfield MA 02048
• Manufacturer Contact: sam rajkumar ; 1 analog way; wilmington, MA 01887
• MDR Report Key: 23314394
• Report Number: 3000130829-2025-00008
• Device Sequence Number: 4967684
• Product Code: MWI
• UDI-Device Identifier: 00860006382322
• UDI-Public: (01)00860006382322(17)261120
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K243216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification,Replace
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ADCP1100
• Device Catalogue Number: ADI12294
• Device Lot Number: 30438102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female